Licence details
Ferring Pharmaceuticals Pty Ltd
Adenovirus
Replication incompetent and expression of human interferon alfa-2b protein
This licence allows Ferring Pharmaceuticals Pty Ltd to conduct clinical trials of a genetically modified (GM) human adenovirus for the treatment of bladder cancer in Australia.
The GM treatment is based on a human adenovirus, which has been genetically modified by removing DNA sequences to make it safer for patients and introducing a gene encoding a protein with anti-tumour effects. It can enter urothelial and tumour cells and produce the protein with anti-tumour effects within the infected cells.
The GMO will be manufactured overseas and imported into Australia. Up to 25 patients with non-muscle invasive bladder cancer will receive the GMO at clinical trial sites and hospitals in Australia, over a period of 5 years.
The Risk Assessment and Risk Management Plan (RARMP) concluded that the clinical trials pose negligible risks to people or the environment. However, as this is a clinical trial under limited and controlled conditions, licence conditions have been imposed to:
- restrict when and where the trial can take place
- limit the size of the trial
- restrict the spread and persistence of the GMO.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Documents
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.